Nutraceuticals and Vascular Remodelling (MALTRO)

Marcello Rattazzi

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Liposcudil Plus

Study type: Observational

Funder types: Other

Identifiers

NCT04433429

3497/AO/15

Details and patient eligibility

About

Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).

Enrollment: 30 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Total Cholesterol > 150 mg/dl and < 250 mg/dl;
• Triglycerides > 150 mg/dl and < 500 mg/dl;
• Fasting glucose < 126 mg/dl;
• Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.

Exclusion criteria

• Total Cholesterol > 250 mg/dl
• Triglycerides > 500 mg/dl
• Previous statin therapy (last 6 months);
• Treatment with hypoglycemic agents and/or fasting glucose > 126 mg/dl;
• Chronic gastrointestinal disorders;
• Chronic kidney disease (eGFR < 60 ml/min/1.73 m2);
• Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
• Proven intolerance to any component of the nutraceutical product;
• Pregnancy or breastfeeding.

Trial design

30 participants in 1 patient group

RYR plus CoQ

Description:

333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily

Treatment:

Dietary Supplement: Liposcudil Plus